A Pharmacokinetic Study of CKD-501 in Patients With Impaired Hepatic Function

NCT02005744 | Completed Phase 1 DMC

• 1 other identifier: 19HI13018
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate pharmacokinetics of CKD-501 in patients with impaired hepatic function compared with normal hepatic function.

Conditions

Liver Dysfunction

Keywords

CKD-501

Outcome Measures

Primary Outcomes (1)

• Area Under the Concentration(last) and Cmax of CKD-501

  Sampling timepoint(hours) : 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48

  0 to 48 hours

Secondary Outcomes (4)

• Tmax, Area Under the Concentration(inf), T1/2 and Clearance/F of CKD-501 and its metabolite

  0 to 48 hours

• Fraction Unbound of CKD-501 and its metabolite

  1 and 8 hours

• Area Under the Concentration(last) and Cmax of the metabolite

  o to 48 hours

• Metabolic ratio(metabolite/CKD-501)

  0 to 48 hours

Other Outcomes (4)

• Vital signs

  up to 8 days

• Physical examination

  up to 8 days

• Laboratory tests

  up to 8 days

Study Arms (4)

Child Pugh A

EXPERIMENTAL

CKD-501 will be administered to patients who are included Child Pugh A

Drug: CKD-501

Child Pugh B

EXPERIMENTAL

CKD-501 will be administered to patients who are included Child Pugh B

Drug: CKD-501

Subject who are matched Child Pugh A

EXPERIMENTAL

CKD-501 will be administered to the Subjects who are matched Child Pugh A

Drug: CKD-501

Subject who are matched Child Pugh B

EXPERIMENTAL

CKD-501 will be administered to the subjects who are matched Child Pugh B

Drug: CKD-501

Interventions

CKD-501 DRUG

CKD-501 0.5mg, PO(per oral), once

Also known as: Lobeglitazone

Child Pugh A; Child Pugh B; Subject who are matched Child Pugh A; Subject who are matched Child Pugh B

Eligibility Criteria

• Age: 19 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \[The subjects with impaired hepatic function\]
• The subjects who are 19 to 64 years old
• The subjects with stable hepatic disease and impaired hepatic function as Child-Pugh A or B
• Body Weight ≥ 55kg
• If females, Negative for pregnancy test at the screening and pre dose of Day 1
• The subjects who agreed with performing contraception during the study
• The subjects who agreed with written informed consent
• \[The subjects with normal hepatic function\]
• The subjects who are 19 to 64 years old
• The subjects who are matched impaired hepatic function by gender, age(± 5years) and body weight(± 10kg)
• If females, Negative for pregnancy test at the screening and pre dose of Day 1
• The subjects who agreed with performing contraception during the study
• The subjects who agreed with written informed consent

You may not qualify if:

• \[The subjects with impaired hepatic function\]
• The subjects with impaired hepatic function as Child-Pugh C
• The subjects had a portosystemic shunt surgery
• The subjects had a liver transplantation or unsuitable for the study by the investigator's judgement(for examples, hepatic encephalopathy grade 3 or 4, stroke, heart failure, cancer etc.) but The subject is eligible to participate if had not chemotherapy or radiofrequency ablation therapy within 6months)
• The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product
• The subjects who took drugs or medicine which can be effected in metabolism of Cytochrome P450 within 14days prior to Day 1
• Positive for anti-HIV Ab or venereal disease research laboratory etc.
• \[The subjects with normal hepatic function\]
• The subjects with liver disease or abnormal Laboratory test(Asparate transaminase \>1.25 fold of upper normal limit, Alanine transaminase\>1.25 fold of upper normal limit, Total bilirubin \>1.5 fold of upper normal limit)
• The subjects have a gastrointestinal disease or surgery which can be effected in absorption of Investigational product
• Estimated Glomerular filtration rate \< 60 mL/min/1.73m2 by Modification of Diet in Renal Disease formula
• Positive for HBsAg, anti-Hepatitis C virus Ab, anti-HIV Ab or venereal disease research laboratory
• The subjects with high blood pressure or low blood pressure(systolic blood pressure \>150mmHg or \<100mmHg, diastolic blood pressure\>90mmHg or \<60mmHg)
• The subjects who took drugs or medicine which can be effected in metabolism of Cytochrome P450 within 14days prior to Day 1 etc.

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Yonsei University Severance Hospital

Soeul, South Korea

Location

MeSH Terms

Conditions

Liver Diseases

Interventions

lobeglitazone

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Min Soo Park, Ph.D. M.D

  Severance Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2013
• First Posted: December 9, 2013
• Study Start: March 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: July 4, 2016

Record last verified: 2014-05

Locations

KR (1)